Abbott Laboratories recalls ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detec…

Recall date

May 24, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2079-2019

FDA classification

Class III

Brand / firm

Abbott Laboratories

Sold / distributed

Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed worldwide to ALGERIA, ANDORRA, AUSTRIA,…

Why it was recalled

Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination of human B type natriuretic peptide (BNP) in human EDTA plasma.